Senior Human Factors Design Engineer

1 week ago

Boston, Massachusetts, United States Medtronic Full time
About the Role

We are seeking a highly skilled Senior Human Factors Design Engineer to join our team at Medtronic. As a key member of our Surgical Robotics Organization, you will play a critical role in executing human factors efforts within the System Architecture Center of Excellence.

Key Responsibilities
  • Lead Human Factors projects supporting business portfolio
  • Moderating usability testing of prototypes with end users and customers
  • Aiding in data collection and root cause analysis during usability testing
  • Usability risk analysis
  • Contribute inputs to design guidance to reduce use risk and improve ease of use
  • OR procedure observation / contextual inquiry
  • Moderate interviews with end users and customers for the purpose of gathering insights
  • Contribute and maintain human factors program documentation as needed for the UE File
  • Participation in planning of human factors program activities
  • Aiding team with preparation of usability-related regulatory documentation for pre-market approval submissions
  • Aid in identifying use-related issues upon post-market launch and provide recommendations of risk control enhancements
  • Mentorship/coaching role to junior HF staff
Requirements
  • BS in Human Factors or a closely-related field (such as Biomedical Engineering, Industrial Design) with 4+ years' experience; MS or higher preferred with 2+ years' experience (specific experience in medical device development is strongly preferred)
  • Experience planning, conducting, and documenting usability testing in a medical device use context; ability to generate design guidance that addresses usability test findings preferred
  • Experience planning, scaling, documenting, and executing human factors program activities in accordance with FDA guidance and other relevant international standards (e.g., IEC 62366, IEC 60601, ISO 14971)
  • Experience with risk analysis as specifically applied to human factors (e.g., UEA, AFMEA, UFMEA, URA techniques)
  • Prior experience managing outside contractors/agencies preferred
  • Experience working with complex devices involving both software and hardware preferred
  • Capable of working independently and with limited oversight in human factors disciplines
  • Excellent analytical, organizational, oral communication, and written communication skills required
  • Detail-oriented with strong commitment to quality and to the workplace with the ability to efficiently multitask
  • Interact and communicate with all levels of employees within the Company, as well as suppliers, customers and peers effectively
  • Comply with policies, procedures, standards and rules of the Company
  • Maintain quality assurance policy consistent with standards
  • Maintain work area in a clean, orderly and safe manner
  • Punctual, regular and consistent attendance
  • Perform all other job-related duties as assigned
  • Must be willing and able to travel ~25% of the time primarily between Boston, MA and North Haven, CT facilities via car or train as well as domestically and internationally at times
  • Must respond to changing requirements and working conditions including changing deadlines and project requirements and strict time constraints
Software Skills
  • Microsoft Office (Word, Excel, PowerPoint, Project); experience with qualitative analysis tools a plus
About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people.

From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves.

We have the talent, diverse perspectives, and guts to engineer the extraordinary.

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